Kornimate/medical-research-clean huggingface dataset:
a safety and effectiveness study of aroplatin in patients with advanced colorectal cancer resistant to standard therapies

Conditions: Colorectal Neoplasms

Summary: to determine the rate of response and duration of reponse following therapy with aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. secondary objectives are to determine safety and tolerability of the aroplatin therapy.

primary objective: * to determine response rate (rr; complete and partial response\[cr,pr\] and duration after therapy with aroplatin (liposomal nddp, l-nddp) in subjects with locally recurrent, unresectable or metastatic colorectal cancer refractory to 5-fu/leucovorin or capecitabine, and irinotecan. secondary objective: * to determine safety and tolerability of the aroplatin therapy. this is a single-arm, open-label phase ii study. subjects refractory to 5-fu/leucovorin or capecitabine, and irinotecan therapies will be enrolled. dosing will be every four weeks with individual dose escalations and adjustments for toxicity.

Eligibility criteria:
inclusion criteria: * colorectal cancer, locally recurrent, unresectable or metastatic disease (ajcc); * measurable disease (recist criteria); * cancer refractory to 5-fu/leucovorin or capecitabine, and irinotecan; * ecog performance score of 0-2; * adequate hematopoietic, liver and renal function; * adequate cardiac function (maximum of class ii, nyha); * women of child-bearing potential must have a negative urine or serum pregnancy test; * signed written informed consent; * subjects must be willing to to be followed during the course of treatment/observation and follow-up. exclusion criteria: * other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer; * pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study; * prior therapy with oxaliplatin; * known brain metastases; * active, uncontrolled infection or other serious medical illnesses; * subjects may not be using or have used any investigational therapy during four weeks before start of the protocol treatment.

Keywords: colorectal neoplasms colorectal cancer colorectal carcinoma colorectal tumor neoplasms, colorectal unresectable metastatic refractory
comparison of passive and active joint mobilization for chronic ankle instability

Conditions: Musculoskeletal Manipulations; Chronic Instability of Joint; Ankle Joint

Summary: the features of cai were confirmed through studies that 64% to 77% had extra-articular conditions mainly related to calf tendon disorder. in addition, joints are laxity, sensory motors are deficient, and the range of dorsi flexion is decreased. this study is to investigate the effects of active joint mobilization(ajm) under weight-bearing conditions to stimulate various proprioceptors for cai with deficiency in sensorimotor and postural control.


Eligibility criteria:
inclusion criteria: * first ankle sprain one year before clinical trial * a score of less than 24 on the cumberland ankle instability tool (cait) * no ankle sprains occurred within 4 weeks of starting the test * two or more more ankle sprains in the past month exclusion criteria: * if you have a history of lower extremity surgery * in case of receiving treatment for the affected ankle within 1 month * if you have a psychological problem
a trial of sertraline in young children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this study is a control trial of sertraline (zoloft) in children aged 2 to 5 years old inclusive with autism spectrum disorder. the trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. the researchers hope to show improvements in language and social deficits.

this is a single center study and the uc davis mind institute for autism spectrum disorder (asd) patients aged between 2 years and 5 years old inclusive funded by the health resources and services administration (hrsa). it is a double-blind control trial of sertraline (zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. the researchers are investigating the use of this selective serotonin reuptake inhibitor (ssri) in asd because a retrospective study has shown significant improvements in language and social deficits. there is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (bdnf) and the stimulation of neurogenesis when an ssri is given early on in the development of animal models of down syndrome. the researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors. the aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with asd who are between the ages of 2 years and 5 years old inclusive. at baseline, the researchers will assess behavioral and cognitive development. each participant will be involved in this trial for a period of six months. this will include three visits to the uc davis mind institute and eight phone calls. the researchers will also assess the side effects of the sertraline treatment throughout the study.

Eligibility criteria:
inclusion criteria: * documentation of autism spectrum disorder with diagnostic and statistical manual for mental disorders-fifth edition, criteria as well as a standardized autism assessment such as the autism diagnostic observation schedule or the autism diagnostic interview-revised. * subject between the ages of 24-72 months of age. * a reliable parent or caregiver who can report the side effects and communicate effectively with the research team. * stable medications during the two months prior to enrollment. * currently receiving interventions in the community or school for autism spectrum disorder exclusion criteria: * current or past selective serotonin reuptake inhibitor treatment. * other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.

Keywords: autism spectrum disorder behavior sertraline treatment
mid-transverse process combined with erector spinae block versus paravertebral plane block

Conditions: Lung Cancer

Summary: this study aims to compare efficacy of mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries.

thoracic paravertebral block (tpvb) application has also been used in recent years due to the lower incidence of side effects. the erector spinae plane block (espb)has been used as a part of multimodal analgesia in recent years. in espb is aimed to treat the postoperative pain of the thoracoabdominal region by injecting a local anesthetic into the interfacial area under the erector spinae muscle . espb creates an effect that covers the posterior and lateral thorax by affecting the dorsal rami and branches of the spinal nerves . midtransverse process to pleura (mtp) block is less invasive as the position of the needle in this block is midway between the transverse process' posterior border and the pleura. due to fenestrations present in the superior costotransverse ligament (sctl), the drug reaches the paravertebral space

Eligibility criteria:
inclusion criteria: * lung cancer patients for thoracotomy surgeries. * physical status american society of anesthesiologists (asa )ii, iii. * age ≥ 18 and ≤ 65 years. * body mass index (bmi): \&gt; 20 kg/m2 and \&lt; 35 kg/m2 exclusion criteria: * patient refusal * physical status asa iv, * age \&lt;18 years or \&gt;65 years * bmi \&lt; 20 kg/m2 and \&gt;35 kg/m2 * known sensitivity or contraindication to drug used in the study (local anesthetics, opioids). * history of psychological disorders and/or chronic pain. * contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy. * severe respiratory, cardiac, hepatic or renal disease.
effect of different sedation and analgesia strategies on patients with mechanical ventilation

Conditions: Respiratory Insufficiency

Summary: most patients in icu are treated with a combination of analgesics and sedatives in most cases. due to the different mechanism of different sedative and analgesic drugs, different antagonistic or synergistic effects may occur when combined with drugs, resulting in different clinical effects, especially significant effects on ventilators for patients with assisted breathing. therefore, this study hopes to compare the effects of different sedative and analgesic drug combinations on the duration of mechanical ventilation for patients with ventilators, so as to guide the clinical adoption of a more reasonable sedative and analgesic scheme.


Eligibility criteria:
inclusion criteria: * adults who are treated with sedation and analgesia for invasive mechanical ventilation exclusion criteria: * they have baseline severe cognitive impairment; were pregnant or breast-feeding; were blind, deaf ; had second-degree or third-degree heart block or bradycardia requiring intervention; had an allergy to the experimental drugs; had an indication for benzodiazepines; were anticipated to have immediate discontinuation of mechanical ventilation; were expected to have neuromuscular blockade for more than 48 hours; were in a moribund state; or had received mechanical ventilation for more than 96 hours before meeting all inclusion criteria.
subject preference for scalp psoriasis treatment

Conditions: Scalp Psoriasis

Summary: the scalp is one of the most common affected sites in psoriatic patients as 79% of them have scalp involvement.it has also a psychological aspect with 31% of patients with scalp psoriasis indicating distress. topical agents remain the mainstay of treatment for scalp psoriasis. however, they are not always ideal because they might be inconvenient and messy to use, stain or damage hair. the test shampoo, clobetasol propionate shampoo 0.05% (marketed in the usa under the tradename of clobex®) was developed to provide the strongest available corticosteroid as a short-contact therapy in order to improve the chances of it being effective and reduce the potential for traditional side-effects. the objective of this study is to compare subject's overall preference between clobetasol propionate shampoo 0.05% and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis.

this study will be a multi-centre, investigator blinded, randomized, cross-over, intra-individual comparison in three parallel groups. in each parallel group, clobetasol propionate shampoo, 0.05% will be compared to one of the three chosen competitors, following a cross-over design.

Eligibility criteria:
inclusion criteria: * male or female subjects, 18 years of age or older, * subjects with moderate to severe scalp psoriasis, * subjects who signed written informed consent prior to any study procedures. exclusion criteria: * subjects who need systemic treatment for their body psoriasis, * subjects who are at risk in terms of precautions, warnings and contra-indication, * female subjects who are pregnant, nursing or planning a pregnancy during the study, * subjects with a specific washout period for topical treatment(s) on the scalp, * subjects with a specific washout period for systemic treatment(s).

Keywords: 1 galderma, 2 scalp psoriasis 3 subject preference 4 clobetasol propionate 5 shampoo
vardenafil vs sildenafil for the treatment of pulmonary hypertension of the newborn

Conditions: PPHN

Summary: the goal of this clinical trial is to learn if drug vardenafil works to treat pulmonary hypertension in newborns, it will also learn about the safety of vardenafil. the main questions it aims to answer are: does vardenafil lower the pulmonary hypertension in newborns? what medical problems do participants have when taking vardenafil? researchers will compare drug vardenafil to drug sildenafil to see if drug vardenafil works better to treat pulmonary hypertension. participants will be divided into 2 groups , one group will take oral drug: vardenafil and the other group will take oral drug: sildenafil every day. pulmonary hypertension will be measured daily until it returns to normal. keep a diary of the symptoms and any complications

a double blind controlled trial in children's hospital damascus between 5/2023 and 9/2024 on newborns up to 4 d old diagnosed with pphn, patients were allocated randomly into one of the 2 arms of the study, group sildenafil and group vardenafil, both medicines administered orally, management of the patients was the same in both groups except for the investigated drug, pulmonary hypertension and resistance were measured by echo at diagnosis time and every 24 hours later on till normalization of pulmonary pressure, at the end of recruitment data was collected and analyzed to confirm the safety of vardenafil and compare the efficacy of vardenafil to sildenafil

Eligibility criteria:
inclusion criteria: * gestation age: 28 weeks or more exclusion criteria: * cardiac deformity, inability to administer the drug orally

Keywords: pphn sildenafil vardenafil
screening of obstructive sleep apnea syndrome in residents of a unit of long-term care under mixed food

Conditions: Obstructive Sleep Apnea Syndrome

Summary: obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over 60 years with major consequences especially on the cardiovascular system. this syndrome consists of a staff of the pharyngeal muscles. these muscles are also involved in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet, logically leading to atrophy of the muscles aerodigestive crossroads. muscle wasting ent induced a mixed food could promote collapsibility of vas, exposing the individual to a higher risk of apnea and hypopnea during sleep. the objective of this study is to determine if there is a significant increase in the prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term care units, receiving a mixed food compared to residents in supply to normal texture.


Eligibility criteria:
inclusion criteria: * resident of a unit of long-term care * recipient or affiliated with social security * signature of consent by the patient, guardian or person of trust and mixed food or normal texture food exclusion criteria: * osa diagnosed and treated earlier * patients with an abnormal upper airway out edentation * patients unable to give informed consent and having no confidence in individual capacity to do so. * patients with a gastrostomy or jejunostomy

Keywords: seniors mixed food normal texture food
a registry study on safety surveillance of dazhuhongjingtian (a chinese medicine injection) used in china

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to make a cohort event monitoring to see whether and how dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions

safety surveillance on chinese medicine injection is an important problem that needs to be sorted out ,because in mainland china hospitals ,chinese medicine injection are used widely. population for taking medicine characteristics,the incidence rate of adr and other uncertain factors influence can few be found now.a registry study for dazhuhongjingtian injection safety surveillance with 3000 patients will be conducted from june.2017 to dec.2019.eligibility criteria patients who will use dazhuhongjingtian injection in 4 selected hospitals from2017-2019.

Eligibility criteria:
inclusion criteria: - an anticipated sample size was caculated in this study, about 3000. patients using dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals exclusion criteria: none
impact of brafv600e intratumor heterogeneity in thyroid cancer treated with tyrosine kinase inhibitors

Conditions: Differentiated Thyroid Cancer

Summary: * background: brafv600e is the most frequent oncogene in differentiated thyroid cancer (dtc) occurring in about 50% of cases. clinical trials with tyrosine kinase inhibitors (tki) with specific activity against braf in metastatic radioiodine-resistant dtc (mrr-dtc) are ongoing. very recently it has been demonstrated that dtc often consists of a mixture of tumor cells with wild-type and mutant braf. the subclonal occurrence of brafv600e in mrr-dtc could disable the therapy with braf targeted tki and be responsible of the frequent defeats of this treatment. a therapeutic strategy based upon braf inhibitors in tumors bearing subclonal brafv600e could be initially successful hitting the tumor cells expressing the oncogene, and after the initial tumor growth arrest and/or shrinkage, the oncogene negative cells insensitive or less sensitive to the treatment, could restart the growth of the tumor causing the progression of the disease and the escape from the clinical response. * aims: to determine the impact of subclonal brafv600e on the efficacy of braf inhibitors in the treatment of mrr-dtc. * study design: primary tumor tissues will be analyzed for the presence of brafv600e by pyrosequencing or other quantitative assay. if available, synchronous metastases and post-therapy metachronous metastases will be analyzed as well. the clinical response will be determined according to recist, and the association with the percentage of brafv600e alleles will be evaluated. attention will be paid to the possible difference of brafwild-type/brafv600e ratio between primary tumors and synchronous metastases, primary tumors and post-therapy metachronous metastases, and between responsive and resistant synchronous tumor lesions.


Eligibility criteria:
inclusion criteria: * subjects any sex any age with metastatic or unresectable thyroid carcinoma treated with tyrosine kinase inhibitors * evidence of measurable disease by response evaluation criteria in solid tumors (recist) * availability of study end points including best response, duration of response, and time to disease progression (based on recist), clinical progression, or death * availability of tumor tissue samples, frozen or formaldehyde fixed-paraffin embedded from block, genomic dna already extracted from tumor tissue exclusion criteria: * concurrent hashimoto's thyroiditis

Keywords: thyroid cancer tyrosine kinase inhibitors braf sorafenib pazopanib sunitinib cabozantinib
type 2 diabetes patients with renal impairment

Conditions: Type2 Diabetes

Summary: the purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of dwp16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal impairment.


Eligibility criteria:
inclusion criteria: * aged ≥ 19 years at the time of screening test * body weight of ≥ 50.0 kg to ≤ 90.0 with a body mass index (bmi) of ≥ 20.0 to ≤ 45.0 * have been diagnosed with type 2 diabetes exclusion criteria: * have clinically uncontrolled or unstable hepatic, neurological, immune system, respiratory, hemato-oncology, cardiovascular, or psychiatric disorder (subject with chronic disease such as hypertension, diabetes, and hyperlipidemia that is well controlled or stable is eligible to participate in the study based on investigator's judgement) * history of gastrointestinal diseases, dialysis, kidney transplantation, hiv, hepatitis b or c, acute or chronic infection, recent diabetic ketoacidosis, or gastrointestinal surgery that may affect the absorption of the study drug * received sglt2 inhibitors or drugs of thiazolidinedione class within 6 weeks of scheduled ip administration day * clinical laboratory test values are outside the accepted normal range at screening * ast (sgot), alt (sgpt) \> 2 x the upper limit of normal * repeatedly confirmed qtc interval \> 450 ms * sitting systolic blood pressure \ 180 mmhg or sitting diastolic blood pressure \ 110 mmhg after resting for more than 3 minutes * other exclusive inclusion criteria, as defined in the protocol
microbiota is related with increasing infection rates after splenectomy

Conditions: Gut Microbiota; Spleen Injury; Infection

Summary: studies has shown an increasingly infection rate after splenectomy, and there is a potential correlation between microbiota and immune system. investigators suppose that increasingly infection can be associated with the alteration composition of the gut microbiota after splenectomy. it's investigators' aim to discover if any difference of gut microbiota is exist in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim toreduce and mitigation infection rate through controlling gut microbiota.

the spleen is crucial in regulating immune homoeostasis through its ability to link innate and adaptive immunity and to protect against infections. asplenia refers to the absence of the spleen, a disorder that is rarely congenital and is more frequently as a result of surgery. splenic hypofunction, as a result of asplenia can lead a series of changes in body systems. recent study has show an increasingly infection rate after splenectomy including abdominal infection, pulmonary infection and cranial cavity infection. the gastrointestinal tract plays host to a diverse and metabolically complex community of microorganisms. recent literature suggests that organisms in the gastrointestinal tract, referred to collectively as gut microbiota, play an indispensable role in the maintenance of host's homeostasis. study has proved a potential correlation between microbiota and immune system. lymphocyte, in either peripheral circulation or mesenteric lymph node, altered can lead to an composition change in microbiota. investigators suppose that this phenomenon can be associated with the alteration of the resident commensal microenvironment after splenectomy compared to commensal communities. it's investigators' aim to discover if any difference of gut microbiota is exist in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim toreduce and mitigation infection rate through controlling gut microbiota.

Eligibility criteria:
inclusion criteria: * all the patients underwent an total splenectomy in the first affiliated hospital of harbin medical university from january 1st, 2015 to may 1st, 2017. each participant provided a fresh stool sample in hospital when following-up. exclusion criteria: * use antibiotics and probiotics 3 mouth before samples collection. * other severe abdomen injury * underwent abdomen organ resection surgery * other digestive system disease

Keywords: gut microbiota splenectomy infection immune cytokines
one touch verioiq us clinical outcomes study

Conditions: Diabetes

Summary: evaluation of the clinical benefits of one touch verioiq system

evaluation of the clinical benefits of the one touch verioiq system. the system contains pattern alert technology and comes with educational material (pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Eligibility criteria:
inclusion criteria: * male or female at least 18 to 80 years old * ada guidelines for fpg and ppg appropriate * a1c greater or equal to 8.0% and less than or equal to 10.5% * lab a1c greater than or equal to 8.0% in the last 6-12mths * diagnosed with type 1 or 2 in at least last 1 year * on stable dose of oads for at least 3mths prior to screening * willingness to test 7 bgm tests per day * willing to remain on same therapy as baseline (mdi) for duration of study exclusion criteria: * unlikely to be compliant to study procedures * has or has currently used one touch verioiq * is on fixed doses of insulin for mdi therapy

Keywords: blood glucose monitor pattern management pattern guide education